The U.S. FDA granted accelerated approval for the Biologics License Application for Axogen Inc.'s Avance, an acellular nerve allograft that serves as a scaffold for nerve regrowth, for treatment of patients with sensory, mixed and motor peripheral nerve discontinuities. The company expects Avance to be commercially available in the second quarter of 2026.
After raising more than twice as much as expected in its March IPO, Kestra Medical Technologies Inc. appears poised to repeat its success with an upsized secondary offering as well. The Kirkland, Wash.-based company initially planned to offer 5.5 million shares in its second pass at the market but increased the number of shares to 6 million two days later when it set the price at $23 per share. The projected gross proceeds of $138 million provide a nice addition to the $232 million raised nine months ago.
Glucagon-like peptide-1 (GLP-1) receptor agonists clearly help patients shed pounds, but many regain all - or more - of the weight once they discontinue the medications. Fractyl Health Inc. could offer an enduring solution with its Revita procedure. Six-month results from its open-label REVEAL-1 cohort of individuals with obesity who lost 15% or more of their total body weight on a GLP-1 therapy maintained that loss after discontinuing the drugs and undergoing the Revita procedure.
Proving its latest addition to the Farapulse pulsed field ablation (PFA) platform is no turkey, Boston Scientific Corp.'s Farapoint PFA catheter received CE mark as the U.S. celebrated Thanksgiving. Farapoint is indicated for ablation of the cavotricuspid isthmus, specifically to treat right atrial flutter.
GE Healthcare Technologies Inc. agreed to purchase medical imaging company Intelerad Medical Systems Inc. for $2.3 billion in cash, boosting its capabilities in cardiology and radiology. The deal, expected to close in the first half of 2026, advances GE Healthcare's dual strategies of expanding from primarily inpatient products to outpatient and ambulatory care settings and tripling its cloud-enabled products by 2028.
Solventum Corp. continued its restructuring with a second significant acquisition this year, the proposed purchase of privately held Acera Surgical Inc. for $725 million in cash plus up to $125 in contingent cash payments based on achievement of specified milestones. St. Louis.-based Acera projected that its synthetic wound care products will bring in $90 million in sales this year.
Dexcom Inc. received U.S. FDA clearance for its Smart Basal CGM-integrated basal insulin dosing optimizer. Designed for adults with type 2 diabetes using glargine U-100 long-acting insulin therapy, Smart Basal uses data from Dexcom’s G7 15 Day sensor with doses logged by the user to personalize recommendations and adjust long-acting insulin doses, with direction from the patient’s health care provider.
Medtronic plc posted solid fiscal year second-quarter results led by the cardiovascular business with 9.3% growth. The Affera Sphere-9 pulsed field ablation system tripled the company’s sales in the hot PFA segment and pushed the cardiac ablation solutions unit to 71% growth, a nice uptick from the nearly 50% seen in its Q1.
A rapid diagnostic test from Ocean Dx SAS delivered gold standard performance in a clinical evaluation that points to a potential shift in how sepsis is identified and treated. The assay, which detects more than 1,000 bacterial species directly from whole blood, returned 100% sensitivity and 100% specificity compared with reference blood cultures, with results reported in five hours. Further, the test tripled the number of infections identified.
Dexcom Inc. executives may have thought a $30 million beat of the consensus estimates for third quarter revenue and 20% year-over-year organic growth provided a treat to shareholders, but investors seemed to feel tricked instead. The continuous glucose monitoring powerhouse saw its share price drop a frightening 17% in the first two hours of trading on Oct. 31, pushing it down by one-third from its peak of $89.53 in late July. Investors appear to have been spooked by the company’s conservative projections for 2026, following issues with its G7 sensor, which management said have been largely resolved.
